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news.The US Food and Drug Administration (FDA) has granted priority review status to PaxVax's biologics license application (BLA) for single-dose oral cholera vaccine Vaxchora.
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The agency has set 15 June 2016 as the action date for Vaxchora BLA. If approved, it would become the only anti-cholera vaccine in the US.
PaxVax’s BLA submission was based on results from a 10 and 90-day cholera challenge study, as well as two other safety and immunogenicity trials in healthy adults.
The company enrolled over 3,000 participants in the phase 3 trials to evaluate Vaxchora at sites in Australia and the US.
Vaxchora met primary endpoints, demonstrating efficacy in an immunogenicity study of adults aged 46 to 64 years.
PaxVax CEO Nima Farzan said: "Travelers residing in the U.S. currently have very few options to protect themselves against cholera when going abroad, and we are pleased with the progress we are making in bringing an effective single-dose cholera vaccine to the U.S. market.
"We are also pleased to announce that Vaxchora has been granted priority review status, a critical step in the process of being awarded a Priority Review Voucher."
Vaxchora is a single-dose oral vaccine featuring the cholera strain CVD 103-HgR. The strain has been in-licensed from the University of Maryland School of Medicine’s Center for Vaccine Development in 2010.